FDA Compliant Retirement of Computer Systems

Instructor: Dr. Ludwig Huber
Product ID: 700457
Training Level: Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This FDA compliant training for computer system will present strategies for complaint and efficient system retirement. Attendees will receive reference documents for easy implementation.

Why Should you Attend:

Retirement of computer systems used in FDA and equivalent international environments is part of the validation lifecycle and should follow well defined and documented processes. While earlier phases are well understood the industry is unsure on what to do when the systems are taken out of service. Most critical are strategies and procedures to retrieve data after system retirement. This seminar will present strategies for complaint and efficient system retirement. Attendees will receive reference documents for easy implementation.

Areas Covered in the seminar:

  • FDA and international regulations and guidelines
  • Impact of FDA's narrow approach for Part 11
  • Planning for system retirement
  • Strategies for data migration and retrieval
  • Risk based archiving of e-records
  • Criteria for reprocessing
  • Responsibilities for system retirement
  • Performing system retirement
  • Documentation of the retirement process
  • Costs of system retirement

Who Will Benefit:

  • Everybody involved in software and computer system validation
  • IT managers and administrators
  • QA managers and personnel
  • Validation specialists
  • Suppliers of software and computer systems
  • Documentation department
  • Operational departments (manufacturing, QC labs)
  • Regulatory affairs
  • Training department
  • Consultants

Additional benefits:

Attendees will receive the presenter’s SOP for Retirement of Computer Systems, a retirement plan and a checklist for system retirement

Note: These complimentary hand-outs will be sent to customers on request. Please email for these documents, stating your order number, and they will be emailed to you within 4 working days.

Instructor Profile:

Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. For more information, visit Dr. Huber’s website:

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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